The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Change in Hearing Loss After 4 Weeks of Treatment [ Time Frame: 28 days ]

To compare the change in hearing using the QuickSIN test (speech in noise performance) from baseline (Day 1 to Day 28) between AUT00063 and placebo. The QuickSIN test measures the level of signal compared to the noise that is required to achieve 50% recognition. The test is administered in a sound booth at 70-dB HL binaurally via insert-ear phones. Three lists are administered to each individual subject and the threshold or 50% signal-to-noise ratio (SNR) is calculated as the mean of the three lists completed. Each list consists of six sentences with five key words to be scored per sentence. The sentences are presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to-noise ratios which decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult).

Secondary Outcome Measures:

Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28 [ Time Frame: 28 days ]

Final Average GDT Across-Channel at Day 28: Change from Baseline; FAS Population

Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28 [ Time Frame: 28 days ]

Final Average GDT Within-Channel at Day 28: Change from Baseline; FAS Population

To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG [ Time Frame: 42 Days ]

To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and electrocardiography (ECG)

3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks

Drug: AUT00063

600 mg, orally, once a day, for 4 weeks

Other Name: Experimental

Placebo Comparator: (AUT00063 placebo capsules)

3 capsules of placebo, to take orally once daily with food for 4 weeks

Drug: Placebo

orally, once a day, for 4 weeks

Other Name: Comparator

Detailed Description:

Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).

AUT00063 is an experimental new medicine that enhances the action of these specific channels and so may treat the brain component of these hearing problems.

The main purpose of this study is to try to demonstrate an improvement in a speech-in-noise deficit after 4 weeks of treatment with the study drug versus the placebo (dummy drug which does not contain the drug). Subjects will undergo a safety follow-up after the treatment period.

Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.).

The amount of drug in the blood will also be measured. It is expected that around 70 people (at least 35 in each arm) with age-related hearing loss may take part in the study. The study participants will be recruited at around 13 sites in the USA.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Not a current or previous user of hearing aids. You are eligible if you were noncompliant and stopped wearing a hearing aid device >6 months earlier for intermittent use or >3 years if you were a full-time consistent user of hearing aid devices

Not be dependent on alcohol or drugs

Have not participated in another research study within 30-days

If female, you must confirm to be non child bearing (post-menopausal for at least 12-months or surgically sterile)

If male, you must confirm to use a barrier method (condom)

Not be a professional musician

No history of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease deemed clinically significant by the study doctor

While you are in the study, you must:

Follow the instructions you are given

Come to the study centre for all visits with the study doctor or study staff

Answer the telephone at the scheduled date and time for the 2 telephone calls

Tell the study doctor or study staff about any changes in your health or the way you feel

Tell the study doctor or study staff if you want to stop being in the study at any time

Bring your Diary to each visit

Not eat or drink anything containing Grapefruit beginning 7-days before Baseline visit (Visit 3, Day 1) until the end of the study

Use sun screen if you plan to sunbathe

Not use headphones or headsets at high volume

Not use hearing aids or devices at any time during the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345031